Elon Musk’s US brain-microchip firm Neuralink Corp. has received authorization from the Food and Drug Administration (FDA) to conduct its first human clinical trials for its prototype brain-computer interface (BCI), Link.
The company said the FDA’s approval marked a crucial first step that would someday enable their technology to help many people.
California-based Neuralink is developing Link to treat patients with vision and mobility conditions by using neural signals, allowing the blind to see and the paralyzed to walk, as stated by Musk.
The brain-implant firm did not go into detail about the goals of the test and only stated that it had no immediate plans to recruit volunteers. The extent of the green-lighted study has also yet to be known.
Neuralink would not be the first to implant a chip in the human brain. In July 2021, the FDA authorized human testing of Synchron Inc.’s endovascular BCI device. The New York-based company released its findings from earlier trials of four participants in Australia in January this year.
Major Challenges and Issues Lie Ahead of Neuralink
The authorization came after Neuralink’s earlier struggles to secure FDA approval for the in-human study.
Citing seven current and former employees of the company, it was reported in March that Neuralink first sought the FDA’s support in early 2022, although it was rejected due to several major issues.
The FDA pointed out safety concerns over the device’s lithium battery, the potential for the implant’s wires to migrate to other areas of the brain, and the challenge of safely removing the chip without damaging brain tissue.
Furthermore, Neuralink has been criticized for allegedly mistreating animals, a claim the firm has denied. However, the company is facing certain federal probes for potentially violating the Animal Welfare Act, including purportedly transporting contaminated devices extracted from monkeys.
While the FDA has green-lighted the trial, brain implants are still years away from becoming widespread and commercialized. If Neuralink’s study turns out a success, the company can proceed with a feasibility study and, finally, a pivotal study, which is similar to a phase III clinical trial for a drug.
